Blockbuster Biologics Review | Issue 27

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to biosimilars in Q2 2025. We will continue to monitor developments in these post-grant challenges and litigations and provide you with regular updates.

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Post-Grant Challenges and Litigations
In this section, we break down post-grant challenges and Biologics Price Competition and Innovation Act (BPCIA) litigations, including the types of claims being challenged, the number filed each year, and their outcome. Notably, the current institution rate for inter partes review (IPR) challenges to patents that claim biologics—excluding IPRs that have settled or otherwise been terminated—stands at 58%.
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FDA—Biosimilar Approvals
This section tracks all US biosimilar approvals. The number of approved US biosimilars is 74, with the most recent approvals being Jobevne (bevacizumab-nwgd), Bomyntra and Conexxence (denosumab-bnht), Omlyclo (omalizumab-igec), Osenvelt and Stoboclo (denosumab-bmwo), and Merilog (insulin aspart-szjj).
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Legislative and Regulatory Updates
In this section, we highlight the six bipartisan bills directed to drug patents and pricing advanced to the full Senate, and the reintroduced bipartisan Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act and Patent Eligibility Restoration Act (PERA). On the regulatory front, the FDA published a Biosimilar User Fee Act (BsUFA) III Regulatory Research Pilot Program research roadmap to guide research proposals and collaborations as they seek BsUFA III research funding opportunities.
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Supporting Documents
This section provides a product-by-product breakdown of biologics-related patents that have been subject to an IPR, including the challenged claims.
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For more information, contact authors Christopher J. Betti, Ph.D., Kelly A. Plummer, Ph.D., Maarika L. Kimbrell, Maria E. Doukas, and Margaret C. Harney.